Immunization of Patients With Non Small Cell Lung Cancer (NSCLC)

Stopped early · Phase 1

Conditions studied: Non Small Cell Lung Cancer (NSCLC)

In brief

The study of the vaccine will proceed in two stages after the method of Simon (102). In the first stage, 15 patients will be accrued and treated. If two or fewer objective immunologic responses occur, the study will be terminated. If 3 or more responses are observed, the study will proceed to the second stage, accruing an additional 22 patients. If the second stage is complete and a total of 9 or more immunologic responses are observed among the 37 patients treated, the treatment response rate for the vaccine will be considered high enough to warrant further study. Conversely, if the evaluation of the vaccine concludes at the first stage, or if 8 or fewer total immunologic responses occur after completing the second stage, the vaccine will not be considered for further study.

Key facts

Study ID

NCT00793208

Run by

Theresa Whiteside, PhD

People needed

1

Starts

2008-12-01

Expected to finish

2015-11-01

Last updated by the study team

2019-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent conforming to the institutional guidelines obtained from the patient.
• A diagnosis of non-small cell lung cancer (NSCLC), subjects will undergo or have had surgical resection.
• Age 18 or above.
• Karnofsky performance status > 70
• Adequate hematologic function:
• Absolute neutrophil count > 1,000/mm3
• Absolute lymphocyte count > 1,000/mm3
• Hemoglobin > 9 g/dL
• Platelets > 100,000/mm3
• Liver function tests:
• Bilirubin (total) < 1.7 mg/dL
• Alkaline phosphatase < 252 u/L
• SGOT < 108 u/L
• Kidney profile:
• Serum electrolytes
• Sodium 136-146 mEq/L
• Potassium 3.5-5.0 mEq/L
• Bicarbonate 21-31 mEq/L
• Chloride 98-107 mmol/L
• Serum creatinine < 3 x ULN
• BUN 8-26 mg/dL
• At least a 12 week interval should have elapsed between vaccination and any prior radiation therapy, chemotherapy or any other treatment. Patients should have recovered from surgery and adjuvant treatment.

You may not qualify if…

• Subjects will be EXCLUDED from participation in the study if any of the following apply:
• One or more of the Inclusion Criteria are not met.
• A significant history or current evidence of cardiac disease including, but not limited to: congestive heart failure, coronary artery disease, angina pectoris, uncontrolled hypertension, serious arrythmias or myocardial infarction within the previous six months.
• Evidence of active infection requiring antibiotic therapy.
• Active intracranial metastases. Patients with previously resected intracranial disease and/or previously irradiated intracranial metastases that have been stable for four weeks are eligible.
• Pregnant or lactating women. Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated on study.
• Patients requiring systemic corticosteroids (unless patient has had NO STEROIDS IN THE PAST 4 WEEKS).
• Autoimmune disease including, but not limited to, rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis
• Patient must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
• Subject is not a candidate for complete resection of the carcinoma via pneumonectomy, lobectomy, bilobectomy, extended wedge resection or anatomic segmentectomy with or without sleeve resection as noted in the surgical plan..
• Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration.
• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least 5 years prior to registration.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Where it is running

• University of Pittsburgh Cancer Institute - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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